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This annex is relevant for living modified organisms (LMOs) only where there is potential for phytosanitary risks from the LMO associated with some characteristic or property related to the genetic modification. Other phytosanitary risks associated with the organism should be assessed under other appropriate sections of ISPM No. 11 or under other appropriate ISPMs.
The information requirements outlined in section 1.3 may be needed in determining the potential for an LMO to be a pest.
Potential phytosanitary risks for LMOs
Potential phytosanitary risks for LMOs may include:
a. Changes in adaptive characteristics which may increase the potential for introduction or spread, for example alterations in:
- tolerance to adverse environmental conditions (e.g. drought, freezing, salinity etc.)
- reproductive biology
- dispersal ability of pests
- growth rate or vigour
- host range
- pest resistance
- pesticide (including herbicide) resistance or tolerance.
b. Adverse effects of gene flow or gene transfer including, for example:
- transfer of pesticide or pest resistance genes to compatible species
- the potential to overcome existing reproductive and recombination barriers resulting in pest risks
- potential for hybridization with existing organisms or pathogens to result in pathogenicity or increased pathogenicity.
c. Adverse effects on non-target organisms including, for example:
- changes in host range of the LMO, including the cases where it is intended for use as a biological control agent or organism otherwise claimed to be beneficial
- effects on other organisms, such as biological control agents, beneficial organisms, or soil fauna and microflora, nitrogen-fixing bacteria, that result in a phytosanitary impact (indirect effects)
- capacity to vector other pests
- negative direct or indirect effects of plant-produced pesticides on non-target organisms beneficial to plants.
d. Genotypic and phenotypic instability including, for example:
- reversion of an organism intended as a biocontrol agent to a virulent form.
e. Other injurious effects including, for example:
- phytosanitary risks presented by new traits in organisms that do not normally pose phytosanitary risk
- novel or enhanced capacity for virus recombination, trans-encapsidation and synergy events related to the presence of virus sequences
- phytosanitary risks resulting from nucleic acid sequences (markers, promoters, terminators, etc.) present in the insert.
The potential phytosanitary risks identified above can also be associated with non-LMOs. The risk analysis procedures of the IPPC are generally concerned with phenotypic characteristics rather than genotypic characteristics. However, genotypic characteristics may need to be considered when assessing the phytosanitary risks of LMOs.
If there is no indication that new traits resulting from genetic modifications have phytosanitary risks, the LMO may require no further consideration.
It may be useful to consider potential risks in the context of risks posed by the non-modified recipients or parental organisms, or similar organisms, in the PRA area.
In cases of phytosanitary risks related to gene flow, the LMO is acting more as a potential vector or pathway for introduction of a genetic construct of phytosanitary concern rather than as a pest in and of itself. Therefore, the term "pest" should be understood to include the potential of an LMO to act as a vector or pathway for introduction of a gene presenting a potential phytosanitary risk.
Factors that may result in the need to subject a LMO to stage 2 of the PRA include:
- lack of knowledge about a particular modification event
- the credibility of information if it is an unfamiliar modification event
- insufficient data on the behaviour of the LMO in environments similar to the PRA area
- field experience, research trials or laboratory data indicating that the LMO may pose phytosanitary risks (see sub-sections a. To e. above)
- where the LMO expresses characteristics that are associated with pests under ISPM No. 11
- existing conditions in the country (or PRA area) that may result in the LMO being a pest
- where there are PRAs for similar organisms (including LMOs) or risk analyses carried out for other purposes that indicate a pest potential
- experience in other countries.
Factors that may lead to the conclusion that an LMO is not a potential pest and/or requires no further consideration under ISPM No. 11 include:
- where the genetic modification in similar or related organisms has previously been assessed by the NPPO (or other recognized experts or agencies) as having no phytosanitary risk
- where the LMO is to be confined in a reliable containment system and not be released
- evidence from research trials that the LMO is unlikely to be a pest under the use proposed
- experience in other countries.
For further information on international standards, guidelines and recommendations concerning phytosanitary measures, and the complete list of current publications, please contact the:
SECRETARIAT OF THE INTERNATIONAL PLANT PROTECTION CONVENTION
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By mail: |
IPPC Secretariat |
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Plant Protection Service |
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Fax: |
+39-06-57056347 |
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E-mail: |
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Website: |
INTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES (ISPMS)
International Plant Protection Convention, 1997. FAO, Rome.
ISPM No. 1: Principles of plant quarantine as related to international trade, 1995. FAO, Rome.
ISPM No. 2: Guidelines for pest risk analysis, 1996. FAO, Rome.
ISPM No. 3: Code of conduct for the import and release of exotic biological control agents, 1996. FAO, Rome.
ISPM No. 4: Requirements for the establishment of pest free areas, 1996. FAO, Rome.
ISPM No. 5: Glossary of phytosanitary terms, 2004. FAO, Rome.
Glossary Supplement No. 1: Guidelines on the interpretation and application of the concept of official control for regulated pests, 2001. FAO, Rome.
Glossary Supplement No. 2: Guidelines on the understanding of potential economic importance and related terms including reference to environmental considerations, 2003. FAO, Rome
ISPM No. 6: Guidelines for surveillance, 1997. FAO, Rome.
ISPM No. 7: Export certification system, 1997. FAO, Rome.
ISPM No. 8: Determination of pest status in an area, 1998. FAO, Rome.
ISPM No. 9: Guidelines for pest eradication programmes, 1998. FAO, Rome.
ISPM No. 10: Requirements for the establishment of pest free places of production and pest free production sites, 1999. FAO, Rome.
ISPM No. 11: Pest risk analysis for quarantine pests, including analysis of environmental risks and living modified organisms, 2004. FAO, Rome.
ISPM No. 12: Guidelines for phytosanitary certificates, 2001. FAO, Rome.
ISPM No. 13: Guidelines for the notification of non-compliance and emergency action, 2001. FAO, Rome.
ISPM No. 14: The use of integrated measures in a systems approach for pest risk management, 2002. FAO, Rome.
ISPM No. 15: Guidelines for regulating wood packaging material in international trade, 2002. FAO, Rome. [published in 2003]
ISPM No. 16: Regulated non-quarantine pests: concept and application, 2002. FAO, Rome.
ISPM No. 17: Pest reporting, 2002. FAO, Rome.
ISPM No. 18: Guidelines for the use of irradiation as a phytosanitary measure, 2003. FAO, Rome.
ISPM No. 19: Guidelines on lists of regulated pests, 2003. FAO, Rome.
ISPM No. 20: Guidelines for a phytosanitary import regulatory system, 2004. FAO, Rome.
ISPM No. 21: Pest risk analysis for regulated non-quarantine pests, 2004. FAO, Rome.
